Abbott announced that the FDA has approved the Xience Xpedition Everolimus Eluting Coronary Stent System for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥ 2.25mm to ≤ 4.25mm. Everolimus (Novartis) is an mTOR kinase inhibitor shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.

The Xience Xpedition approval is supported by clinical evidence from the Xience family of drug eluting stents. This includes long-term safety data from >45,000 patients across >100 studies, which allows it to be proven safe for direct stenting.

Xience Xpedition will be available in both rapid exchange (RX) and over-the-wire (OTW) configurations, with diameters ranging from 2.25mm–4mm (including a unique 3.25mm diameter) and lengths from 8mm–38mm. Abbott is launching this product immediately.

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